Analytical R&D Scientist – Method Development & GMP

RXinsider LTD.; Piscataway Township, Northern (NJ, KY); Hybrid; USD 75,000 - 90,000; Full time

Benefits offered by this job

Bonus program

Incentive opportunity

Job summary

Amneal is seeking a mid-level Scientist-2 to support analytical development of pharmaceutical oral dosage forms. The role involves qualifying/validating analytical methods, analyzing APIs, excipients, and finished dosage forms, and maintaining analytical equipment in a cGMP environment.

Responsibilities include developing and validating methods for qualification and release, providing timely responses to inquiries, and ensuring development deadlines are met while adopting new technologies.

Qualifications

• Bachelor's degree in Chemistry or related field required
• 3+ years pharma experience with Bachelor's; 1+ year with Master's preferred

Responsibilities

• Performs analysis and release of APIs, excipients, in-process materials, and finished drug products to support formulation development in compliance with cGMP and SOPs.
• Develops and optimizes new analytical methods for qualification and release testing; performs method validation and stability-indicating studies.
• Provides timely responses to internal and external inquiries and ensures deadlines for development schedules are met.
• Evaluates, recommends, and implements new analytical technologies and instrumentation for testing.
• Assists with training other analytical development team members.
• Stays abreast of new developments in analytical technologies and contributes to GMP-compliant lab operations.

Skills

GMP knowledge

Methods development

SOP writing

Analytical equipment know-how

Education

Bachelor's in Chemistry or related science

Master's in Chemistry or related science

Tools

HPLC

GC

TLC

MS

Job description

Amneal is seeking a mid-level Scientist-2 to support analytical development of pharmaceutical oral dosage forms. The role involves qualifying/validating analytical methods, analyzing APIs, excipients, and finished dosage forms, and maintaining analytical equipment in a cGMP environment.

Responsibilities include developing and validating methods for qualification and release, providing timely responses to inquiries, and ensuring development deadlines are met while adopting new technologies.